Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutide): Påverkan på kroppsvikt

Dulaglutide är inte indicerat för viktminskning. Dulaglutide 1,5 mg var associerat med viktminskning under hela varaktigheten av AWARD-studierna.

Detailed Information

In phase 3 studies, treatment with dulaglutide 1.5 mg was associated with sustained weight reduction from baseline over the duration of the studies including the longest study (AWARD-5, 104-week final endpoint) (Table 1).1-10

The LSM change in BW from baseline to primary endpoint ranged from

  • -0.87 kg (AWARD-4) to -3.10 kg (AWARD-10) with dulaglutide 1.5 mg treatment, and

  • +0.20 kg (AWARD-1 , AWARD-4) to -2.60 kg (AWARD-5, AWARD-10) with dulaglutide 0.75 mg treatment.1-10

In the AWARD-11 study, using the treatment-regimen estimand, the LSM changes in BW from baseline to primary endpoint at 36 weeks were 

  • - 3.0 kg with dulaglutide 1.5 mg treatment 

  • - 3.8 kg with dulaglutide 3 mg treatment, and

  • - 4.6 kg with dulaglutide 4.5 mg treatment.11

Table 1. Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studies1-11ab

Primary Endpoint

DULA 1.5 mgc

DULA 0.75 mgc

Comparatorc

P Value

AWARD-31 – Comparator – MET

26 weeks

-2.29

-1.36

-2.22

p<.05 DULA 1.5 mg vs DULA 0.75 mg
p<.05 DULA 0.75 mg vs MET

AWARD-52– Comparator – SITA and PBOa

52 weeks

-3.03

-2.60

-1.53

p<.001 both DULA vs SITA

AWARD-63 – Comparator – LIRA 

26 weeks

-2.90

NA

-3.61

p=.011 DULA 1.5 mg vs LIRA

AWARD-84 – Comparator – PBO

24 weeks

-0.91

NA

-0.24

p=.120 DULA 1.5 mg vs PBO

AWARD-15 – Comparator – EXE BID and PBOa

26 weeks

-1.30

0.20

-1.07

p<.001 both DULA vs EXE
p<.001 DULA 1.5 mg vs DULA 0.75 mg

AWARD-106 – Comparator – PBO

24 weeks

-3.10

-2.60

-2.10

p=.028 DULA 1.5 mg vs PBO
p=.26 DULA 0.75 mg vs PBO

AWARD-27– Comparator – GLA

52 weeks

-1.87

-1.33

1.44

p<.001 both DULA vs GLA

AWARD-98 – Comparator – PBO

28 weeks

-1.91

NA

0.50

p<.001 DULA 1.5 mg vs PBO

AWARD-49 – Comparator – GLA

26 weeks

-0.87

0.18

2.33

p<.001 both DULA vs GLA

AWARD-710 – Comparator – GLA

26 weeks

-2.81

-2.02

1.11

p<.0001 both DULA  vs GLA

AWARD-1111– Comparator – DULA

 

DULA 4.5 mg

DULA 3 mg

DULA 1.5 mgd

P Value

36 weekse

-4.6

-3.8f

-3.0

p<.001 DULA 4.5 mg vs DULA 1.5 mg
p=.001 DULA 3 mg vs DULA 1.5 mg

36 weeksg

-4.7

-4.0

-3.1

p<.001 DULA 4.5 mg vs DULA 1.5 mg
p=.001 DULA 3 mg vs DULA 1.5 mg

Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BID = twice daily; DULA = dulaglutide; EXE = exenatide; GLA = insulin glargine; LIRA = liraglutide; LSM = least squares mean; MET = metformin; PBO = placebo; SITA = sitagliptin.

a LSM Changes in body weight from baseline to primary time point are not shown for placebo.

b Data presented as LSM kg

c Unless otherwise noted.

d Active control group.

e Treatment regimen estimand.

f Nominal p-value, DULA 3 mg did not meet superiority criteria under graphical testing procedure.

g Efficacy estimand.

References

1. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37(8):2168-2176. https://doi.org/10.2337/dc13-2759

2. Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761

3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. https://doi.org/10.1016/S0140-6736(14)60976-4

4. Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634

5. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8):2159-2167. https://doi.org/10.2337/dc13-2760

6. Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381. https://doi.org/10.1016/S2213-8587(18)30023-8

7. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249. https://doi.org/10.2337/dc14-1625

8. Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937

9. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9

10. Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018;6(8):605-617. https://doi.org/10.1016/S2213-8587(18)30104-9

11. Frias JP, Bonora E, Ruiz LM, et al. 357-OR: Efficacy and safety of dulaglutide 3mg and 4.5mg vs. dulaglutide 1.5mg: 52-week results from AWARD-11 [abstract]. Diabetes 2020 Jun; 69(Supplement 1): https://doi.org/10.2337/db20-357-OR

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

BW = body weight

LSM = least squares mean

Datum fӧr senaste ӧversyn 2020 M08 18


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